ARDSLEY, N.Y.--(BUSINESS WIRE)--Aug 13, 2012 - Acorda
Therapeutics, Inc. (Nasdaq: ACOR) today announced top line results
from a post-marketing commitment study evaluating a 5mg dose of
dalfampridine-ER to improve walking in people with multiple
sclerosis (MS). The study failed to confirm efficacy of the 5mg
dose.

The study randomized 430 participants across three treatment
arms: placebo, 5 mg or the currently marketed dose of 10 mg of
dalfampridine-ER, twice daily. Baseline characteristics were
measured at a single visit after randomization, following a
qualifying screening visit. Study drug was then given for 4 weeks.
Participants returned after 2 weeks on study drug for interim
measurements (Visit 2), and again at 4 weeks (Visit 3).

The primary outcome was the change in walking speed
(feet/second) on the Timed 25-Foot Walk (T25FW) test at Visit 3,
measured at the time of peak plasma drug concentration, versus
baseline.

Improvements in the primary outcome for the 5 mg dose (0.423
ft/sec, p=0.457) and the 10 mg dose (0.478 ft/sec, p=0.107) at
Visit 3 were not statistically significant compared to placebo
(0.363 ft/sec). The AMPYRA® (dalfampridine) Extended
Release Tablets, 10 mg registration studies used a consistent
response analysis to allow for the variability in MS-related
symptoms, including walking ability. The design of the current
study required a single endpoint analysis that had not been used
previously in the AMPYRA development program. In a post-hoc
analysis, T25FW data were analyzed with methods similar to those
used in the pivotal studies, combining all measures prior to
treatment as the baseline and all measures on treatment as the
on-drug value. The average change from baseline in walking speed
was significantly greater for the 10 mg group compared to placebo
(0.443 vs. 0.303 ft/sec, p=0.014) but not for the 5 mg group (0.366
vs. 0.303 ft/sec, p=0.292).

In addition, using a responder definition of average improvement
in walking speed of at least 20% from baseline, similar to an
analysis presented in the AMPYRA prescribing information, the 10 mg
group showed significantly more responders than the placebo group
(44% vs. 27%, p=0.004). The 5 mg group did not show a significant
increase in response over placebo (32% vs. 27%, p=0.366).

“We believe the current study, together with the AMPYRA
registration studies, continue to show that 10 mg twice daily is
the appropriate, safe and effective dose. The 5mg twice daily dose
of dalfampridine-ER failed to show efficacy over placebo on the
primary or secondary measures. The 10 mg twice daily dose, which
has consistently shown efficacy in our well-controlled clinical
trials, did not meet the previously untested primary outcome
measure selected for this study. We believe that this was due to
increased patient variability, related to the study design.
However, the 10 mg dose showed significant improvements in the
6-Minute Walk and in responder analyses of the Timed 25-Foot
Walk,” said Enrique Carrazana, M.D., Acorda's Chief Medical
Officer. “We are particularly encouraged by the 6-Minute Walk
result, as this marks the first time that data on AMPYRA's effects
have been assessed on this measure.”

No new safety signals were observed in this study. No seizures
were reported. Two participants experienced serious adverse events
in each of the 5 mg and the 10 mg treatment groups, including loss
of consciousness in one patient in the 10 mg group who had
discontinued dalfampridine-ER four days prior to the event. Adverse
events that occurred in the combined dalfampridine-ER group at a
rate of at least 2% greater than the placebo group included:
urinary tract infection (8.0% vs. 5.6% placebo), nausea (7.7% vs.
3.5% placebo), dizziness (7.7% vs. 2.1% placebo), insomnia (6.3%
vs. 4.2% placebo) and upper respiratory tract infection (2.8% vs.
0.7% placebo). Overall, adverse events were consistent with the
U.S. Food and Drug Administration (FDA)-approved product
labeling.

The study results will be provided to FDA and presented in
peer-reviewed scientific forums. The Company is continuing to
analyze data from the study.

AMPYRA is currently approved by the FDA as a treatment to
improve walking ability in people with MS. This was demonstrated by
an increase in walking speed. The only approved dosage strength of
AMPYRA is 10 mg, which is taken twice daily. As specified in the
product labeling, AMPYRA tablets should not be split, crushed,
chewed or otherwise compromised, as doing will compromise the
extended release properties of the tablet.

To participate in the conference call, please dial 866-730-5769
(domestic) or 857-350-1593 (international) and reference the access
code 83883059. The presentation will be available via a live
webcast on the Investor section of
www.acorda.com.

A replay of the call will be available from 10:30 a.m. ET on
August 13, 2012 until midnight on September 13, 2012. To access the
replay, please dial 888-286-8010 (domestic) or 617-801-6888
(international) and reference the access code 35919782. The
archived webcast will be available for 30 days in the Investor
Relations section of the Acorda website at
www.acorda.com.

Important Safety Information

AMPYRA can cause seizures; the risk of seizures increases with
increasing AMPYRA doses. AMPYRA is contraindicated in patients with
a prior history of seizure. The majority of seizures occurred at
the recommended dose and in patients without a history of seizures,
and generally within days to weeks of starting therapy. Discontinue
AMPYRA use if seizure occurs.

AMPYRA is contraindicated in patients with moderate or severe
renal impairment (CrCl less-than or equal to 50 mL/min); the risk
of seizures in patients with mild renal impairment (CrCl 51-80
mL/min) is unknown, but AMPYRA plasma levels in these patients may
approach those seen at a dose of 15 mg twice daily, a dose that may
be associated with an increased risk of seizures; estimated CrCl
should be known before initiating treatment with AMPYRA and
monitored at least annually during treatment with AMPYRA.

AMPYRA should not be taken with other forms of 4-aminopyridine
(4-AP, fampridine), since the active ingredient is the same.
Urinary tract infections were reported more frequently as adverse
reactions in patients receiving AMPYRA 10 mg twice daily compared
to placebo.

The most common adverse events (incidence greater-than or equal
to 2% and at a rate greater than the placebo rate) for AMPYRA in MS
patients were urinary tract infection, insomnia, dizziness,
headache, nausea, asthenia, back pain, balance disorder, multiple
sclerosis relapse, paresthesia, nasopharyngitis, constipation,
dyspepsia, and pharyngolaryngeal pain.

For full U.S. Prescribing Information and Medication Guide for
AMPYRA, please visit:
www.AMPYRA.com.

AMPYRA is a potassium channel blocker approved as a treatment to
improve walking in patients with multiple sclerosis (MS). This was
demonstrated by an increase in walking speed. AMPYRA, which was
previously referred to as Fampridine-SR, is an extended release
tablet formulation of dalfampridine (4-aminopyridine, 4-AP), and is
known as prolonged-, modified, or sustained-release fampridine
(FAMPYRA®) in some countries outside the United
States (U.S.).

In laboratory studies, dalfampridine extended release tablets
has been found to improve impulse conduction in nerve fibers in
which the insulating layer, called myelin, has been damaged. AMPYRA
is being developed and commercialized in the U.S. by Acorda
Therapeutics; FAMPYRA is being developed and commercialized by
Biogen Idec in markets outside the U.S. based on a licensing
agreement with Acorda. AMPYRA and FAMPRYA are manufactured globally
by Alkermes Pharma Ireland Limited, a subsidiary of Alkermes plc,
based on a supply agreement with Acorda.

AMPYRA is available by prescription in the United States. For
more information about AMPYRA, including patient assistance and
co-pay programs, healthcare professionals and people with MS can
contact AMPYRA Patient Support Services at 888-881-1918.

AMPYRA Patient Support Services is available Monday through
Friday, from 8:00 a.m. to 8:00 p.m. Eastern Time. For full U.S.
Prescribing Information and Medication Guide, please visit:
www.AMPYRA.com.

Acorda Therapeutics is a biotechnology company focused on
developing therapies that restore function and improve the lives of
people with MS, spinal cord injury and other neurological
conditions.

Acorda markets
AMPYRA® (dalfampridine) Extended Release
Tablets, 10 mg, in the United States as a treatment to improve
walking in patients with multiple sclerosis (MS). This was
demonstrated by an improvement in walking speed. AMPYRA is marketed
outside the United States as FAMPYRA® (prolonged-release
fampridine tablets) by Biogen Idec under a licensing agreement from
Acorda. AMPYRA and FAMPYRA are manufactured under license from
Alkermes Pharma Ireland Limited.

The Company also markets
ZANAFLEX CAPSULES® (tizanidine hydrochloride)
and Zanaflex tablets, a short-acting drug for the management of
spasticity. Acorda also receives sales royalties on tizanidine
hydrochloride capsules, an authorized generic version of ZANAFLEX
CAPSULES distributed by Watson Pharmaceutics, Inc. under its
agreement with Acorda.

Acorda is developing an industry-leading pipeline of novel
neurological therapies. The Company is studying AMPYRA to improve a
range of functional impairments caused by MS, as well as its use in
other neurological conditions, including cerebral palsy and chronic
stroke. In addition, Acorda is developing clinical stage compounds
AC105 for acute treatment of spinal cord injury and GGF2 for
treatment of heart failure. GGF2 is also being investigated in
preclinical studies as a treatment for neurological conditions such
as stroke and spinal cord injury. Additional preclinical programs
include rHIgM22, a remyelinating monoclonal antibody for the
treatment of MS, and chondroitinase, an enzyme that encourages
nerve plasticity in spinal cord injury.

Forward-Looking Statements

This press release includes forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. All statements, other than statements of historical facts,
regarding management's expectations, beliefs, goals, plans or
prospects should be considered forward-looking. These statements
are subject to risks and uncertainties that could cause actual
results to differ materially, including our ability to successfully
market and sell Ampyra in the U.S.; third party payers (including
governmental agencies) may not reimburse for the use of Ampyra at
acceptable rates or at all and may impose restrictive prior
authorization requirements that limit or block prescriptions; the
risk of unfavorable results from future studies of Ampyra or from
our other research and development programs, including any acquired
or in-licensed programs; the occurrence of adverse safety events
with our products; delays in obtaining or failure to obtain
regulatory approval of or to successfully market Fampyra outside of
the U.S. and our dependence on our collaboration
partner Biogen Idec in connection therewith; competition,
including the impact of generic competition on Zanaflex Capsules
revenues; failure to protect our intellectual property, to defend
against the intellectual property claims of others or to obtain
third party intellectual property licenses needed for the
commercialization of our products; failure to comply with
regulatory requirements could result in adverse action by
regulatory agencies; and the ability to obtain additional financing
to support our operations. These and other risks are described in
greater detail in Acorda Therapeutics' filings with the
Securities and Exchange Commission. Acorda
Therapeutics may not actually achieve the goals or plans
described in its forward-looking statements, and investors should
not place undue reliance on these statements. Forward-looking
statements made in this press release are made only as of the date
hereof, and Acorda Therapeutics disclaims any intent or
obligation to update any forward-looking statements as a result of
developments occurring after the date of this press release.